Human Factors Engineer (Medtech)

TL;DR

Human Factors Engineer (Medtech/SaMD): Leading usability assessments and managing risk for medical devices with an accent on regulatory compliance (IEC 62366-1, ISO 14971, and FDA). Focus on establishing end-to-end usability engineering processes and conducting rigorous summative evaluations for software as a medical device.

Location: Hybrid (3 days per week in the office)

Company

Flo is the world’s #1 health and fitness app dedicated to improving female health through AI-powered, clinically backed digital health solutions.

What you will do

• Establish the Usability Engineering framework at Flo, defining lean end-to-end processes, documentation, and templates compliant with FDA and ISO standards.
• Lead formative and summative evaluations to identify and mitigate use-related risks prior to product release.
• Maintain the Usability Engineering File and refine critical task analysis and hazard-related use scenarios.
• Develop summative evaluation protocols, including acceptance criteria, sample size rationale, and success metrics.
• Coach and upskill the UX Research team on conducting and documenting usability and risk activities.

Requirements

• Degree in Human Factors Engineering or a closely related field.
• Deep fluency in IEC 62366-1, ISO 14971, and FDA regulations.
• Significant experience conducting human factors research for software-based medical devices (SaMD).
• Proven ability to create and maintain compliant usability documentation.
• Strong technical report writing, data handling, and analytical skills.
• Experience working independently as a senior contractor in the medical device industry.

Nice to have

• Experience with software as a medical device specifically within the women’s health space.
• Experience conducting training on FDA Human Factors guidance and IEC 62366-1 implementation.

Culture & Benefits

• Hybrid work model with in-person collaboration 3 days per week.
• Competitive salary with performance incentive schemes.
• Paid holiday, sick leave, and specific female health leave.
• Enhanced parental leave and support for professional growth.
• Unique perks including a 5-week paid sabbatical at the 5-year anniversary.